AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANISEIKONIA INSPECTOR

FDA 510(k)

FDA Class 1 ·Ophthalmic

HEMORX COLD PACK

FDA 510(k)

FDA Unclassified ·Unknown

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

FDA 510(k)

FDA Class 2 ·General Hospital

CERCLAGE WIRE CRIMP BLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

XTRACT SYRINGE KEY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ZEO CE LIGHT & ZEO QUICK PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

SmartEP

FDA 510(k)

FDA Class 2 ·Neurology

DIZZYFIX

FDA 510(k)

FDA Unclassified ·Unknown

MODEL 777 THERAPEUTIC MASSAGER

FDA 510(k)

FDA Class 1 ·Physical Medicine

BARCO 5MP MAMMO, MODEL MDMG-5221

FDA 510(k)

FDA Class 2 ·Radiology

AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A

FDA 510(k)

FDA Class 2 ·Radiology

PROJECT 300 MICROASSAY BP-12, EIA MINILAB

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

STAT FAX(TM)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DRI-DYE CHECK STRIPS (TM)-405

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

REDI-CHECK PHOTMETER Q.A.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT FAX(TM)-2100

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Fitting Software

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·4 devices

Fitting Software

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·10 devices